26 to 50 of 66 ISO 13485 Jobs in the UK

ll also develop prototype algorithmic functions based on data analysis and experimental findings. Additionally, you'll play a role in maintaining adherence to the ISO 13485 quality management system and collaborate effectively with other engineers to support research and development initiatives and the overall project goal Better patient more »

and H&S management systems and their application to high technology & engineering environments Comprehensive understanding of the requirements and application of ISO9001 quality standard, ISO 13485 quality systems for medical devices standard ISO45001 Occupational Health & Safety management standard and ISO14000 environmental management standard Qualified auditor Enthusiastic, inquisitive & self more »

will feed into your constantly evolving test procedure designs. We would love to hear from people who are familiar with industry standards such as ISO 13485, IATF 16949 and you can expect to liaise with the Quality team in terms of compliance and continuous improvement. As a detailed more »

reliability, and safety of medical devices throughout the development lifecycle. - Support the development of risk management documentation, in accordance with regulatory requirements such as ISO13485 and FDA guidelines. Qualifications: - Bachelor's degree in Engineering, Computer Science, or related field. Master's degree preferred. - Proven experience in systems engineering within the … medical device industry, including knowledge of regulatory requirements such as ISO 13485 and FDA guidelines. - Strong understanding of systems engineering principles, including requirements analysis, system design, integration, testing, and validation. - Excellent communication skills with the ability to collaborate effectively with cross-functional teams and stakeholders. - Experience with risk more »

team in performing environmental monitoring in line with the requirements of Standard Operating Procedures (SOP's). Follow all requirements of working in an ISO 13485/FDA regulated environment. The Senior Quality Control Scientist will have the following skills and experience: Batchelors degree in Molecular … biology or similar (or equivalent experience). Recent and relevant in Quality Control for In Vitro Diagnostic (IVD) devices and or reagents within an ISO13485/FDA regulated environment. Hands on experience of PCR and understanding of underlying principles. Familiarity with operating under formal quality systems and practices, such as … ISO13485 and FDA regulations. Practical experience within the Life Science industry would be a distinct advantage. Interested or know someone who might be? If so, get in contact with Darren Holmes @ Vector Recruitment Ltd on 01234 815474 or more »

phasing, mapped reads, signal to noise, quality etc) Working to maintain an accurate and efficient Quality Management System, fulfilling all relevant documentation commensurate with ISO 13485 quality standard Person specification: Masters or PhD in a relevant field such as Applied Mathematics, Biomedical Engineering, Chemistry, Physics, Bioinformatics, or related more »

in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO 13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »

in circuit design, schematic capture, PCB layout, and simulation tools. Experience of version control systems (Altium, PDM etc) Familiarity with regulatory standards such as ISO 13485 and IEC 60601 is a bonus but not a deal-breaker. Excellent problem-solving skills and attention to detail. Ability to thrive more »

advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR and against the external requirements of the relevant regulatory authority (ISO13485, Medical Device Directive MDD 93/42/EEC/Medical Device Regulation (EU) 2017/745 and 21 CFR Part 820) and local quality more »

hire a Quality Engineer to join their team ASAP. Quality Engineer Role Overview : Responsibility for ensuring the implementation of process and their compliance to ISO 13485. Develop, implement and maintain quality assurance processes and support the Manufacturing Quality Team Lead on the promotion and awareness of Quality; Support the more »

are: A background in electronics and/or electro-mechanical assemblies is essential for this role, and experience with Quality management systems such as ISO13485, AS9100 or ISO9001 Electro-mechanical apprenticeship or similar higher education award in this or an associated area e.G., HNC, HND or Level 3 NVQ in more »

and attention to detail Working knowledge of ISO9000/IATF16949 – a plus would be experience in a strong compliance industry such as AS9100 or ISO13485 Internal Auditor qualified or lead auditor preferred against ISO9000/IATF16949 Past experience in a similar role is key Previous experience in the semiconductor industry more »

. Collaborate with the Engineering, Manufacturing and Biology teams working towards regulatory submission and product launch. Adhere to the requirements of working in an ISO 13485/FDA regulated environment. Experience … and skills required to be successful in this position: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Previous experience in writing test protocols in line with Product Requirement Specifications. Degree in Science or Engineering or possess equivalent relevant more »

Experience operating in ISO9001 environment Excellent working knowledge of document management systems, change control and CAPA systems Knowledge and experience of working in an ISO13485 environment is advantageous Good team player and able to work in a fast-paced environment with minimal supervision Keywords: Quality Assurance Specialist, QA Specialist, Regulatory … Specialist, Quality Assurance Manager, QA Manager, ISO9001, ISO 13485 Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency more »

functional teams Experience in root cause investigation and analysis of failures to develop corrective and preventative actions Experience working with regulatory requirements, including AS9100, ISO 13485, and IATF 16949, is a plus Experience working with suppliers and customers more »

To ensure that the project information is well maintained; for example, budget costs, folders, linked projects To ensure compliance to FDA/NPMA/ISO 13485, as well as supporting Medical Device Directive/Regulations documentation Desirable Experience/Qualifications: Degree within project management or a related field more »

when required ROLE REQUIREMENTS · 5 years minimum of relevant medical and healthcare product design experience · Degree in Design or Engineering related discipline · Familiarity with ISO 13485 working processes · Motivation towards the application of human factors to product development · Excellent 3D CAD skills (preferably SolidWorks) ABOUT US At Oxford more »

FAIRS. Quality Manager - Part time/Maternity Cover Position Requirements Proven experience with a Quality Management role ISO9001 internal auditing experience A knowledge of ISO13485 standards is desirable but not essential Experience with QMS and ERP systems Based in a commutable distance of Forest Row Quality Manager - Part time/ more »

resourceful process driven graduate with an interest in quality assurance, who can research, recommend and assist with implementation of appropriate processes for ISO9001 and ISO13485 QA systems. The ideal candidate is an organized and methodical emerging professional who has the skills, confidence and abilities necessary to analyse requirements, sift hard more »

accountable for maintaining compliance of the Quality Management System, input into the management of complaints and post-market activities ensuring that the requirements of ISO 13485:2016, CFR 21 Part 820 IVDD/IVDR are adhered to. The successful candidate shall be responsible for carrying out day-to … timely completion of post market and vigilance related activities Support and input to internal/external audits Essential Knowledge and experience of working to ISO13485, FDA 21 CFR Part 820 Experience of working on post launch IVD or medical device activities in a quality role To find out more about more »

performance and accuracy of medical technologies.Algorithm Development- Develop prototype algorithmic functions based on data analysis and experimental findings.Quality Assurance: Assist in maintaining adherence to ISO 13485 standards and contribute to quality control processes. To be successful in this position you will need:Bachelor's or Master's degree more »

Proven success in leading Medical Device Class IIa or above products through the MDR process. Strong knowledge of European regulatory requirements and standards (MDR, ISO 13485, etc.). Experience managing a regulatory affairs team is desirable. Excellent communication and interpersonal skills, with the ability to interact effectively with more »

Desirable requirements Knowledge of medical device regulations such as 21 CFR 820 (QSR) or the 2017/745 MDR and international standards such as ISO 13485 or other regulated industries. Knowledge of Agile Project Management and/or Scrum Methodology. Both Mechanical and Software Development Projects more »

deployed on mobile devices. Microsoft Azure certifications. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be more »

controlling other medical devices. Microsoft Azure certifications. Familiarity with FDA/MDR/UK MDR medical device software regulation, including relevant standards such as ISO13485, ISO14971, IEC62304, IEC82304, and IEC62366. Deep understanding of the software development lifecycle (SDLC) and best practices in the medical device industry. You will not be more »